Heart failure by the numbers
You already know from treating your patients that those with heart failure (HF) and functional mitral regurgitation (FMR) have limited options. While new surgical and transcatheter treatments have emerged, high FMR recurrence rates persist.
Despite decades of advancements in medications, pacemakers, surgical valve repair and replacement techniques, and minimally invasive valve repair therapies, 20% of HF patients with FMR die in the first year of diagnosis and 50% die within five years.1
1 Mozzafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133:e38-e360.
2 Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123(8):933–44.
Most existing therapies only address the symptoms of FMR
Every year thousands of HF and FMR patients find that the disease has progressed beyond the ability for medications and pacemakers to manage symptoms, but less than 11% are candidates for mitral valve surgery.3
For the vast population of HF and FMR patients who are are at a high risk for open heart surgery, there are limited durable and safe therapies, and physicians are left with only palliative care.
3 Zainab Samad, et al.; Management and outcomes in patients with moderate or severe functional mitral regurgitation and severe left ventricular dysfunction, European Heart Journal, Volume 36, Issue 40, 21 October 2015, Pages 2733–2741, https://doi.org/10.1093/eurheartj/ehv343
Medications may help reduce the risk of stroke and maintain heart rhythm, but for most patients the disease will continue to progress.
A pacemaker may improve heart function, but many patients are unresponsive to this therapy.
Surgical interventions that repair an otherwise-normal valve have an almost 60% recurrence rate in the first two years.4,5
Emerging transcatheter mitral valve procedures for FMR are focused on repairing the annulus or leaflets. These procedures replicate existing surgical approaches that do not target the enlarged left ventricle, which is the cause of functional mitral valve regurgitation.
4 N Engl J Med 2016; 374:344-353January 28, 2016DOI: 10.1056/NEJMoa1512913
5 Hung et. Al. Circulation. 2004;110[suppl II]:II-85–II-90.
The AccuCinch Solution
The AccuCinch® Ventricular Restoration System is a fundamentally different and innovative therapy for HF patients. Early clinical data suggest that AccuCinch may address the shortcomings of current FMR treatments by improving left ventricular function, reducing FMR, and enhancing quality of life for patients.
The success of the device could lay a clear path for a new class of percutaneous ventricular restoration therapies, providing a new treatment option to millions of patients suffering from this disease.
While current technologies replicate surgical or transcatheter procedures that replace or repair an otherwise-normal mitral valve, AccuCinch restores the left ventricle to alleviate HF symptoms.
A Fundamentally Different Therapy
ACCUCINCH VENTRICULAR RESTORATION
AccuCinch is a fundamentally different therapy
Benefits of AccuCinch:
- Directly targets left ventricular (LV) dysfunction and dilation
- Percutaneous trans-femoral arterial-retrograde, not trans-septal or trans-apical
- Preserves the natural mitral structures
- Preserves all future treatment options
AccuCinch treats heart failure and FMR by repairing the LV and slowing the progression of LV dilation
AccuCinch is the only device implanted in the base of the left ventricle.
How it works
- AccuCinch is a fundamentally different design and is the first and only approach of its kind.
- During the AccuCinch procedure, the left ventricle is accessed with a guide catheter through the aortic valve.
- A guide wire is navigated in the left ventricle behind the chordae against the LV wall to provide access for the TracCath.
- The TracCath provides a simple template for anchor placement.
- A series of anchors are placed into the LV wall below the mitral valve.
- A cinching cable connects the anchors and spacers and is cinched and locked in place.
- The cinch cable connects the anchors, separated by spacers to distribute a constant and predictable force across anchors.
- The cinch is secured with a nitinol lock to maintain the cinch.
Promising findings to date
Leading heart centers in the United States and Europe are studying the potential of the AccuCinch® Ventricular Restoration System to repair and reshape the enlarged left ventricle. These cardiologists feel AccuCinch may offer an important new option because it is the first percutaneous therapy to repair the left ventricle, directly targeting the cause of heart failure and FMR.